Wednesday, August 15, 2012

Will FDA CDRH Soon be Reviewing Video Games? ... as medical devices

 . . . the expanding scope of medical device regulations over mobile apps, and now possibly video games:

Will CDRH Soon be Reviewing Video Games? > RAPS > News - Article View:

"Video games aren't traditionally known as medical devices. In fact, there aren't yet any approved by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH), the US's medical device regulatory body. But all that could soon be changing.

At least one company, Boston and San Francisco-based Akili Interactive Labs, is on the verge of taking a video game it has specifically tailored for the treatment of attention deficit/hyperactivity disorder (ADHD) before FDA for potential approval.

Akili's game, named "Project: Evolution,” would work on the presumption of prior research that action-oriented video games can improve a person's concentration. The advantage for the game would be the almost-total mitigation of side effects, likely giving it a highly positive risk-benefit assessment even if it doesn't prove as effective as first-line treatment for ADHD."

'via Blog this'

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